Executive Director, Drug Safety & Pharmacovigilance

As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.

Position Description

Job Title: Executive Director, Drug Safety & Pharmacovigilance
Location: New York, NY preferred, or US-Remote can be considered, Nairobi Kenya, Cape Town South Africa, Amsterdam, Netherlands
Reports To: Chief Executive Officer

Are you a Drug Safety & Pharmacovigilance Leader eager to make in impact in a mission-driven organization? IAVI is seeking an Executive Director, Drug Safety & Pharmacovigilance to lead PV and safety operations – Learn more and apply below!

The Executive Director, Drug Safety & Pharmacovigilance oversees all aspects of clinical Drug Safety operations across all IAVI’s programs. The ED provides strategic leadership for PV and safety operations, as well as any other Drug Safety related work for all current clinical and future commercial programs. IAVI’s current product development portfolio focuses on novel vaccines and monoclonal antibody candidates. The ED drives safety operations, working closely within a cross-functional team of clinical, regulatory, scientific, biostatistics, and operational colleagues. The ED also partners with vendors, external experts, investigators, and government agencies on safety topics. This position reports to the CEO.

Key Responsibilities:

• Accountable for all medical safety aspects of clinical development and post market surveillance of medicinal products in the IAVI portfolio.
• Lead both medical safety and safety operations across clinical programs for IAVI from clinical development planning to completion of execution.
• Lead safety signal assessments and validate safety signals through partnership with clinical development representatives.
• Responsible for the oversight of vendor deliverables and metrics associated with Safety & PV for clinical programs.
• Design and manage DSPV function, including establishing Policies, Standard Operating Procedures (SOPs) and their periodic review.
• Oversee operational support to study teams regarding DSPV activities (e.g., investigator safety training, processing of Serious Adverse Events (SAEs) per protocols, supporting safety assessments activities).
• Lead the process for selection of DSPV vendor(s); maintain oversight of vendor activities related to DSPV (e.g., review quality of Individual Case Safety Reports (ICSRs), monitor compliance with SMPs, Key Performance Indicators/metrics), escalates issues with vendor performance.
• Lead development and implementation of Safety Management Plans (SMPs) needed between IAVI and vendors (e.g., Contract Research Organization).
• Responsible for strategic oversight and overall responsibilities for safety reporting requirements for US, EU and other international territories, as required.
• Management, oversight, and mentorship of the PV team with strategic and tactical vision for future build and planning.
• Participate in health authorities’ interactions regarding safety risk management and inspections.
• Responsible for the establishment and execution of a Safety Governance model, oversight of Drug Safety Committees.
• Heading the strategy for safety regulatory communications, providing oversight of to support submission activities.
• Review of safety components of documents such as protocols, IBs, clinical study reports and publications, regulatory submissions, safety labeling including Core Safety Information, safety sections of label, Risk Management Plans, Integrated Safety Summary, in close partnership with relevant functions.
• Oversee, write or review of periodic or ad-hoc aggregate/safety reports.
• Oversight of case processing and medical review of SUSARs and CSR narratives review, and safety reports follow-up with site investigators, in collaboration with clinical development functions.
• Perform ongoing benefit-risk assessments in collaboration with Clinical Development.
• Ensure compliance with global safety requirements and inspection readiness, ensuring non-compliance events are investigated, remediated, and prevented.
• Collaborate with Quality regarding safety impact assessment of manufacturing issues.
• Develop and maintain Safety Data Exchange Agreements with partners.
• Participate in due diligence and potential in-licensing opportunities as needed.

Education and Work Experience:

• MD Required.
• Minimum of 10 years’ experience in clinical development and minimum of 5 years’ Drug Safety and pharmacovigilance is required.
• Experience with infectious diseases and/or vaccine development is required.
• Experience with DSPV specifically related to vaccine and monoclonal antibody studies, including those conducted in healthy volunteers is highly desirable.
• Global DSPV experience, including oversight of studies conducted in Africa, is highly desirable.

Qualifications and Skills:

• Experience in leading DSPV for clinical development and marketed medicines, vaccines experience preferred.
• Experience in building and leading teams, directly or matrixed, and leading projects.
• Experience in risk management strategies and signal detection strategies.
• Deep knowledge of global DSPV regulations and requirements.
• Experience overseeing safety/PV vendors.
• Experience with regulatory authority inspections.
• Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products.
• Strong business acumen and ability to collaborate with cross-functional partners to achieve enterprise goals.
• Effective written, verbal communication and interpersonal, relationship-building skills.
• Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
• Organized, attention to detail, and able to meet timelines in a fast-paced environment.
• Able to work with a high level of autonomy and independence.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.

Compensation and Benefits Information for US-Based Candidates:

Annual base salary for this position is: $220,000.00 - 290,000.00

Compensation And Benefits Information for NON-US Based Candidates:

Salary is paid in local currency, and is commensurate and competitive with the local labor market

Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)